Five years after insertion of a medical pump that infuses prescription medication through a catheter into the area around the spine to control severe pain, a patient developed an inflammation resulting in permanent paralysis of the lower extremities. He sued the manufacturer in state court alleging negligence, breaches of express and implied warranties, and strict liability. The manufacturer moved to dismiss on the ground that federal law expressly preempted the claims. While the motion was pending, the plaintiff moved to amend, reframing the same claims as a failure to follow FDA regulations requiring the investigation of product complaints and resulting in the failure to warn physicians about the dangers of the pump. The trial court dismissed all claims as preempted by the Food, Drug and Cosmetic Act (FDCA) Medical Device Amendments of 1976 (MDA), 21 U.S.C.A §§ 301 to 399d.
The circuit court held that the original claims were expressly preempted by the MDA. The claims generally challenged the safety and effectiveness of the pump without any hint of an allegation that the manufacturer’s conduct violated FDA regulations. To be successful, the claims would have required the trier of fact, as a matter of state tort law, to conclude that the device should have either been designed differently from what the FDA required through premarket approval, or labeled with warnings different from what the FDA required. Therefore, the district court correctly dismissed the initial complaint.
The claims alleged in the proposed amended complaint were also expressly preempted to the extent they relied on the theory that the manufacturer should have sent a medical device correction notice to physicians, whether or not the FDA ordered it, because FDA regulations permitted the manufacturer to send the notice without prior FDA approval. The circuit court held that when a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is preempted.
The circuit court further held that the MDA did not expressly preempt the plaintiff’s claim that under federal law, the manufacturer failed to comply with its continuing duty to monitor the pump after premarket approval and to discover and report to the FDA any complaints about the product's performance. To the extent the manufacturer’s alleged violations of FDA regulations are actionable under state law, the state obligations parallel the federal requirements, and thus are not expressly preempted. However, the court held, the claim was a disguised claim of fraud on the FDA by failing to report information which it had a duty to report. The policing of this conduct falls within the exclusive province of the federal government, so the claim was impliedly preempted.
See: Stengel v. Medtronic Inc., 2012 WL 1255040 (9th Cir.(Ariz.) Apr 16, 2012) (not designated for publication).